Duns Number:063519193
Device Description: TIDI Positioning Aids - Leg Gray 6.93in x 20.9in x .37in 50 per Case
Catalog Number
32573
Brand Name
TIDI
Version/Model Number
32573
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KXJ
Product Code Name
Table, Radiologic
Public Device Record Key
dbbc1d3f-8e51-40ab-850f-1c29a11862c9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 11, 2016
Package DI Number
00618125162697
Quantity per Package
50
Contains DI Package
01618125162696
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |